Evaluating a device for stroke prevention in patients with atrial fibrillation

The GLACE Study: A Prospective Multi-center Single Arm Study Evaluating the Safety and Performance of the CLAAS Device With ICE Guided LAA Closure.

This study tests a new device to see if it can help prevent strokes in people with atrial fibrillation who can't take blood thinners.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 80 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Conformal Medical, Inc (Industry-sponsored)
• Locations: 3 sites (Praha and 2 other locations)
• Trial ID: NCT06580275 on ClinicalTrials.gov

What this trial studies

This study evaluates the safety and performance of the CLAAS® device in reducing the risk of stroke in patients with non-valvular atrial fibrillation. The procedure involves left atrial appendage closure guided by intracardiac echocardiography (ICE) imaging. Participants will be monitored for outcomes related to stroke prevention and device efficacy. The study aims to provide a non-pharmacologic alternative for patients who cannot use long-term oral anticoagulation.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older with documented non-valvular atrial fibrillation and a high risk of stroke.

Not a fit: Patients who are not at high risk for stroke or those who can safely use long-term anticoagulation therapy may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly reduce the risk of stroke in patients with atrial fibrillation who are unable to take long-term anticoagulants.

How similar studies have performed: Other studies have shown promise in using similar devices for left atrial appendage closure, indicating a potential for success in this approach.

Eligibility criteria

Inclusion Criteria:

1. Male or non-pregnant female aged ≥18 years.
2. Documented non-valvular AF (paroxysmal, persistent, or permanent).
3. High risk of stroke or systemic embolism, defined as CHADS2 score of ≥2 or CHA2DS2-VASc score of ≥3.
4. Has an appropriate rationale to seek a non-pharmacologic alternative to long-term oral anticoagulation including contraindications to long term oral anti-coagulation inclusive of history of intracranial bleed, subdural hematoma, gastrointestinal bleeding, hematuria, epistaxis, falls, and other less common conditions. Also included is the inability to reliably take medications and reluctance to take a blood thinner.
5. Deemed by investigator to be suitable for short term oral anticoagulation therapy but deemed less favorable for long-term oral anticoagulation therapy.
6. Deemed appropriate for LAA closure by the site investigator and a clinician not a part of the procedural team using a shared decision-making process in accordance with standard of care.
7. Able to comply with the protocol-specified medication regimen and follow-up evaluations.
8. The patient has been informed of the nature of the study, agrees to its provisions, and has provided written informed consent approved by the appropriate institutional review board (IRB)/Regional Ethics Board (REB)/Ethics Committee (EC).

Exclusion Criteria:

1. Pregnant or nursing patients and those who plan pregnancy in the period up to one year following the index procedure. Female patients of childbearing potential must have a negative pregnancy test (per site standard test) within 7 days prior to index procedure.
2. Anatomic conditions that would prevent performance of an LAA occlusion procedure (e.g., prior atrial septal defect \[ASD\] or patent foramen ovale \[PFO\], surgical repair or implanted closure device, or obliterated or ligated left atrial appendage).
3. Atrial fibrillation that is defined by a single occurrence or that is transient or reversible (e.g., secondary thyroid disorders, acute alcohol intoxication, trauma, recent major surgical procedures).
4. A medical condition (other than atrial fibrillation) that mandates long-term oral anticoagulation (e.g., history of unprovoked deep vein thrombosis or pulmonary embolism, or mechanical heart valve).
5. History of bleeding diathesis or coagulopathy, or patients in whom antiplatelet and/or anticoagulant therapy is contraindicated.
6. Documented active systemic infection.
7. Symptomatic carotid artery disease (defined as \>50% stenosis with symptoms of ipsilateral transient or visual TIA evidenced by amaurosis fugax, ipsilateral hemispheric TIAs or ipsilateral stroke); if subject has a history of carotid stent or endarterectomy the subject is eligible if there is \<50% stenosis noted at the site of prior treatment.
8. Recent (within 30 days of index procedure) or planned (within 60 days post-procedure) cardiac or non-cardiac interventional or surgical procedure.
9. Recent (within 30 days of index procedure) stroke or transient ischemic attack.
10. Recent (within 30 days of index procedure) myocardial infarction.
11. Vascular access precluding delivery of implant with catheter-based system.
12. Severe heart failure (New York Heart Association Class IV).
13. Prior cardiac transplant, history of mitral valve replacement or transcatheter mitral valve intervention, or any mechanical valve implant.
14. Renal insufficiency, defined as estimated glomerular filtration rate (eGFR) \<30mL/min/1.73 m2 (by the Modification of Diet in Renal Disease equation).
15. Platelet count \<75,000 cells/mm3 or \>700,000 cells/mm3, or white blood cell count \<3,000 cells/mm3.
16. Known allergy, hypersensitivity or contraindication to aspirin, heparin, or device materials (e.g., nickel, titanium) that would preclude any P2Y12 inhibitor therapy, or the patient has contrast sensitivity that cannot be adequately pre-medicated.
17. Actively enrolled or plans to enroll in a concurrent clinical study in which the active treatment arm may confound the results of this study.
18. Unable to undergo general anesthesia.
19. Known other medical illness or known history of substance abuse that may cause non-compliance with the protocol or protocol-specified medication regimen, confound the data interpretation, or is associated with a life expectancy of less than 5 years.
20. A condition which precludes adequate transesophageal echocardiographic (TEE) assessment or ICE guided imaging during the procedure.

Imaging Exclusion Criteria:

1. Left atrial appendage anatomy which cannot accommodate the CLAAS device per manufacturer IFU (e.g., the anatomy and sizing must be appropriate for the test (CLAAS) device in order to be enrolled in the trial).
2. Intracardiac thrombus or dense spontaneous echo contrast consistent with thrombus, as visualized by pre-procedural imaging (TEE or Cardiac CT) or baseline procedural ICE prior to implant.
3. Left ventricular ejection fraction (LVEF) \<30%.
4. Moderate or large circumferential pericardial effusion \>10mm or symptomatic pericardial effusion, signs or symptoms of acute or chronic pericarditis, or evidence of tamponade physiology.
5. Atrial septal defect that warrants closure.
6. High risk patent foramen ovale (PFO), defined as an atrial septal aneurysm (excursion \>15mm or length \>15mm) or large shunt (early \[within 3 beats\] and/or substantial passage of bubbles, e.g., ≥20).
7. Moderate or severe mitral valve stenosis (mitral valve area \<1.5cm2).
8. Complex atheroma with mobile plaque of the descending aorta and/or aortic arch.
9. Evidence of cardiac tumor.

Where this trial is running

Praha and 2 other locations

• Na Homolce Hospital — Praha, Czechia (Recruiting)
• Aarhus University Hospital, Skejby — Aarhus, Denmark (Recruiting)
• University Hospital of Copenhagen — Copenhagen, Denmark (Recruiting)

Study contacts

• Study coordinator: Ken Malomo

Conditions Atrial Fibrillation; Stroke Prevention; Atrial fibrillation; Stroke; ICE; Conformal; LAAO